A $5 Billion Study Takes Its Baby Steps

Being a parent these days is anxious business, with an onslaught of news reports telling you what might be good or bad for your child’s health and development. In many cases, these claims are based on scientific evidence that is preliminary at best, studied only in small subject pools or retrospectively. To comprehensively confirm a link between, say, breast-feeding and body weight or living near a smokestack and asthma, a large epidemiological study that tracks thousands of children from before birth to adulthood is necessary. But that kind of study is very expensive, thanks to costs associated with recruitment, data collection, and analysis over decades of time.

As such, it’s better to do one enormous study of many factors that potentially influence child health rather than several independent and costly experiments. Enter the $5 billion National Children’s Study, a federally-funded project that hopes to track over 100,000 American children from their mother’s womb to age 21 in order to test possible influences – genetic and environmental, positive and negative – to their health. Already 11 years in the making, the study is just completing its warm-up phase, hoping to start the main event in April 2012. But as Daniel Johnson and Angela DeBello presented at the University of Chicago Medical Center Pediatric Grand Rounds earlier this month, the study is already teaching researchers valuable lessons.

“We have a very ambitious agenda,” said Johnson, an associate professor of pediatrics at the Medical Center involved in the Chicago branch of the study. “We’re kind of learning how to do this as we’re going along.”

The Children’s Health Study was authorized as part of the Children’s Health Act of 2000, alongside improvements to child mental health care, anti-violence programs, and day care provider training. While many of the other initiatives have long been implemented, the CHS has taken more time to reach the launchpad due to the mind-boggling logistics involved. In order to break down the roughly 4 million U.S. births each year into a manageable study cohort, the project will collect medical and survey data on growing kids from 105 different counties reflecting almost every region of the country.

It’s a beautiful plan on paper, but executing the recruitment and retention of 100,000 children around the country is immensely difficult. Debello, the vice president and associate director of public health research at the National Opinion Research Center (one of the organizations charged with administering the CHS), said that pilot studies have revealed just how difficult it is to even find pregnant mothers eligible for the study. Researchers have tried surveying homes for women expecting children or trying to have children, working with medical providers who can direct eligible women to the study, and mailed surveys to try and find the right subjects. But the up-to-date numbers presented at grand rounds indicated the low hit rate of this full court press: of 28,000 households originally contacted in Cook County, only 67 women were found to be eligible for the study (and only 49 provided consent to participate).

“It’s pretty overwhelming…the numbers are going to get big very quickly as this study progresses,” DeBello said. “Not surprisingly, it was far more expensive than we expected it to be.”

Hence that large price tag, which Johnson admitted is high, while also suggesting that it could be a bargain in the end. Any costs spent on conducting the study should be weighed against the potential health care costs saved with the information it collects. There’s a lot of room to work with in child health costs, he pointed out – a study in the journal Health Affairs calculated that environmentally-mediated diseases caused by lead exposure, air pollution, and other toxins produced $76 billion in medical costs in 2008 alone. Johnson also pointed out that the results of a similarly large project, the Framingham Heart Study, has prevented an estimated 800,000 deaths despite only being 1/20th the size of the CHS.

“It’s still not clear how successful this study will be,” Johnson said. “But we think that the goals and aspirations are certainly strong reasons to drive us forward.”

Indeed, data from the Children’s Health Study could fill in an important gap in our understanding of human disease, providing high-resolution data about how environmental factors work with genes to keep us healthy or nudge us towards disease. The large strides made by the Human Genome Project and subsequent genomic research could be theoretically combined with CHS data on truly harmful elements in food, air, water and homes to create the ultimate scientifically-supported parenting manual on what to encourage and avoid in a child’s formative years.

“What this is trying to to look at and recognize is how critically important the environment is in every single thing we look at related to disease,” Johnson said. “We have this beautiful map now of genetics, but we know nothing about the environment. It is very important to know how the environment turns on and off different genetic factors as well as other outcomes.”